Valvuloplasty catheter
The present invention provides an aortic valvuloplasty catheter which, in one preferred embodiment, has a tapered distal balloon segment that anchors within the left ventricle outflow track of the patient's heart and a rounded proximal segment which conforms to the aortic sinuses forcing the valve leaflets open. In addition, this embodiment of the valvuloplasty catheter includes a fiber-based balloon membrane, a distal pigtail end hole catheter tip, and a catheter sheath.
1. A valvuloplasty device comprising:
a balloon forming only a single chamber shaped for dilating aortic valve leaflets and having a proximal region, a distal region, and a middle region; said proximal region being composed of a semi-compliant material;
at a first pressure throughout said single chamber, said distal region forms a first diameter that is larger than a second diameter of said proximal region;
at a second pressure throughout said single chamber and being higher than said first pressure, said distal region forms a third diameter that is greater than a fourth diameter of said middle region; at said second pressure, said proximal region having a fifth diameter that is larger than said fourth diameter of said middle region.
2. The valvuloplasty device of claim 1 , wherein said semi-compliant material of said proximal region further comprises a variably compliant material that is expandable at different rates to sequentially lock said balloon from movement and expand the aortic valve leaflets.
3. The valvuloplasty device of claim 1 , wherein said distal region comprises a non-compliant material.
4. The valvuloplasty device of claim 1 , wherein said middle region comprises a non-compliant material.
5. The valvuloplasty device of claim 1 , wherein said middle region is contiguous with said distal region.
6. The valvuloplasty device of claim 1 , wherein said middle region is contiguous with said proximal region.
7. The valvuloplasty device of claim 1 , wherein said semi-compliant proximal region is formed of an elastomeric material.
8. The valvuloplasty device of claim 1 , wherein said proximal region comprises a fabric.
9. The valvuloplasty device of claim 8 , wherein said fabric comprises a braided fabric, a woven fabric, or a knitted fabric.
10. The valvuloplasty device of claim 8 , wherein said fabric comprises yarn, and wherein said yarn comprises partially oriented yarns, oriented yarns, or stretchable yarns.
11. The valvuloplasty device of claim 8 , wherein said distal region has a fabric contained therein.
12. The valvuloplasty device of claim 11 , wherein said fabric comprises braided fabric, woven fabric, or knitted fabric.
13. The valvuloplasty device of claim 11 , wherein said fabric comprises yarn and wherein said yarn comprises partially oriented yarns, oriented yarns, or stretchable yarns.
14. The valvuloplasty device of claim 1 , wherein an external fabric placed around a portion of said balloon limits the opening of said balloon under pressure such that said distal region expands first.
15. The valvuloplasty device of claim 14 , wherein said fabric comprises a braided fabric, woven fabric, or knitted fabric.
16. The valvuloplasty device of claim 14 , wherein said fabric comprises yarn and wherein said yarn comprises partially oriented yarns, oriented yarns, or stretchable yarns.
17. The valvuloplasty device of claim 1 , wherein said fifth diameter of said proximal region is larger than a sixth diameter of said proximal region at said second pressure, such that said aortic valve leaflets can be adjustably dilated.
18. A valvuloplasty balloon for dilating valve leaflets comprising:
only a single chamber formed by said valvuloplasty balloon;
a proximal segment and a distal segment;
at a first lower pressure throughout said single chamber, said distal segment having a first portion with a larger diameter than a second portion of said distal segment and said proximal segment;
at a second higher pressure throughout said single chamber, said proximal segment having a larger diameter than said second portion of said distal segment.
19. A valvuloplasty device for dilating aortic valve leaflets comprising:
a balloon comprising a proximal region having a first compliance, a distal region having a second compliance, and a middle region having a third compliance; said balloon forming only a single chamber;
at a first pressure throughout said single chamber, said distal region having a first diameter that is greater than a second diameter of said proximal region and a third diameter of said middle region;
at a second pressure throughout said single chamber and being higher than said first pressure, said proximal region having a fourth diameter that is greater than a fifth diameter of said middle region;
at said second pressure throughout said single chamber, said distal region having a sixth diameter that is greater than said fifth diameter of said middle region.
20. A valvuloplasty balloon for dilating aortic valve leaflets forming a proximal region, a distal region, and a middle region;
said valvuloplasty balloon forming only a single balloon chamber;
said distal region having a first maximum inflated diameter greater than a second maximum inflated diameter of said middle region;
said first maximum inflated diameter being greater than a second diameter of said proximal region at a first lower pressure throughout said balloon chamber;
said proximal region being formed of a semi-compliant material and having a fourth diameter greater than said second maximum inflated diameter at a second higher pressure throughout said balloon chamber.